A Single Arm, Phase 2 Study of Datopotamab Deruxtecan, Carboplatin, and Pembrolizumab for Treatment-naive Brain Metastases From NSCLC (Non-small Cell Lung Cancer)

This is a Phase II, single-arm, multicenter trial for patients with metastatic non-small cell lung cancer who have brain metastases and no known actionable mutations. Eligible patients will receive a combination of Datopotamab-deruxtecan, Carboplatin, and Pembrolizumab every three weeks for four cycles, followed by maintenance therapy with Datopotamab-deruxtecan and Pembrolizumab until disease progression or intolerable toxicity. Patients with intracranial progression but no systemic progression may receive stereotactic radiosurgery and continue treatment based on the investigator's decision.

NCT Number	NCT06822543
Lead Sponsor	Latin American Cooperative Oncology Group Collaborators: Merck Sharp & Dohme LLC, AstraZeneca
Conditions	Lung Cancer, Non Small Cell Lung Cancer, Brain Metastases
Enrollment	46 participants
Start Date	2025-09-12
Primary Completion	2028-06-30 (estimated)
Study Completion	2028-11-01 (estimated)
Updated on ClinicalTrials.gov	2026-08-14